Delivery System for a Self-Expanding Implant

ABSTRACT

The present disclosure provides a delivery system for a self-expanding implant which includes a sheath which surrounds and constrains the implant prior to delivery and a confining element which surrounds the sheath during storage. The confining element preferably includes elongate members running axially along the sheath, which compress the sheath and the stent to reduce hoop stress in the system without promoting undesired adhesion between layers of the sheath.

PRIORITY

This application is a continuation of Ser. No. 13/704,579, filed Dec.14, 2012, now U.S. Pat. No. 9,161,853, which is a U.S. national stageapplication under 35 U.S.C. §371 of International Application No.PCT/EP2011/059677, filed Jun. 10, 2011, claiming priority to UnitedKingdom Patent Application No. 1010766.2, filed Jun. 25, 2010, and toU.S. Provisional Application No. 61/358,856, filed Jun. 25, 2010, eachof which is incorporated by reference in its entirety into thisapplication.

FIELD

The present invention relates to a delivery system for a self-expandingimplant to line a bodily lumen, which includes a sheath to hold theimplant in a radially compressed configuration prior to and untildeployment in the lumen, when the sheath is withdrawn along the axis ofthe lumen.

BACKGROUND

Self-expanding implants such as stents and stent grafts are oftendelivered to a stenting site within a bodily lumen with the use of acatheter delivery system that is advanced percutaneously andtransluminally. Although most stents and stent grafts are for thecardiovascular system, self-expanding implants can also be deliveredtransluminally to body lumens that carry bodily fluids other than blood.A stent without a coating is often called a “baren stent. Stent graftsthat carry a covering of a material such as expandedpolytetrafluoroethane (ePTFE) are often called “covered” stents or“stent grafts”. A self-expanding stent need not be made of metal butusually is, and that metal is usually a nickel titanium shape memoryalloy commonly known as “NITINOL”.

Given that a self-expanding stent will expand when freed of theconstraint of the catheter delivery system, it follows that the catheterdelivery system confining the stent will be subject to radially outwardpressure from the confined stent, at least at body temperature 37° C.With NITINOL, the outward radial pressure dwindles to zero as thetemperature of the stent is reduced to temperatures around 0° C. andbelow1 with the austenitic crystal lattice changing, as the temperaturereduces, to a martensitic crystal lattice.

Thus, at low temperatures, with the self-expanding stent in themartensitic state, the hoop stress on the sheath surrounding the stentin the delivery system will be relatively low, even to the extent ofbeing close to zero. However, as the temperature rises towards bodytemperature, the radially outward pressure on the confining sheath willincrease. Given that the confining sheath has to be flexible if thedistal end of the catheter delivery system is to advance along atortuous bodily lumen, it is invariably made of a synthetic polymericmaterial rather than metal. Such materials are subject to deformationand the deformation of polymers is a time-dependent phenomenon. Supposethat the self-expanding stent confined within its sheath is stored for aperiod of weeks or months/at room temperature or above. There is thepossibility/perhaps likelihood, that the sheath will stretch and thestent will expand radially to some extent/during the extended period ofstorage.

Even more significant, in coated stents such as those made of Nitinolwith an ePTFE covering, relaxation of the compacted ePTFE layer on thestent also contributes to radial distortion of the sheath.

As the quest continues for ways to deliver implants to ever-smallerdiameter locations within the body, through ever-more tortuous deliverypaths, the pressure on designers of implants and delivery systems toreduce to ever-smaller values the passing diameter of the distal end ofthe catheter system where the implant is located, continues to increase.This pressure pushes designers to think of sheath designs ofever-smaller wall thickness. The smaller the wall thickness of thesheath, the greater the difficulty of resisting the radially outwardpressure imposed on the sheath by the stored implant.

SUMMARY

One promising route to reduce yet further the wall thickness of theconfining sheath is, perhaps paradoxically, to provide that the sheathhas a double layer, namely, as a cylindrical sheath that doubles back onitself. It starts proximally of the implant, extends distally over thefull length of the implant and then is turned back radially outwardly onitself, to continue back along the length of the implant, extendingproximally, to a position proximal of the proximal end of the implant.That turned back end of the sheath, proximal of the implant, can bepulled proximally, when the time comes to release the stent. Thatproximal pull will draw proximally, progressively, the point along thelength of the sheath where the sheath material doubles back on itself.That location where the sheath material doubles back on itselfprogresses proximally along the length of the implant, releasing as itgoes the stent portion radially inside it, so that, when it finallyreaches the proximal end of the implant, the implant is fully releasedinto the bodily lumen.

The present invention represents a way to minimize the wall thickness ofsheath material surrounding a self-expanding implant, so that thepassing diameter of the distal end of a catheter-type implant deliverysystem can be reduced yet further.

According to the present invention there is provided in such a deliverysystem a confining element, preferably in the form of a sleeve, tosurround the sheath during a storage period between placement of theimplant within the sheath and said withdrawal of the sheath, theconfining element serving to reduce the hoop stress in the sheath duringsaid storage period and being removable from the sheath prior toadvancement of the sheath into the said bodily lumen.

It will appreciated by skilled readers that, when the confining elementacts to reduce the hoop stress in the sheath during the storage periodthis, in turn, can reduce the amount of time-dependent creep deformationof the sheath in contact with the stent during the storage period, thatwould otherwise tend to increase the diameter of the sheath, underpressure from the implant within it. In some cases such an increasecould result in increasing the passing diameter of the distal end of thedelivery system to a value higher than is needed for delivery of theimplant, and higher than the minimum that can be achieved with thespecific delivery system prior to any period of extended storage. Inothers, the increase could lead to fouling of the sheath during movementrelative to other components of the delivery system.

It may be convenient to make the confining element as a sleeve of aheat-shrinkable material and shrink it around the sheath duringmanufacture of the delivery system. Such a shrinking step will bring theconfining structure into embracing contact with the distal end of thedelivery system. Thus, the microstructure of the heat shrunk materialcan be more resistant to creep stretching under hoop stress from theconfined implant than the same material prior to being subjected to theheat shrinking step.

The proposal to put the sheath inside a sleeve is of no value unless thesleeve can easily be removed when the time comes to use the deliverysystem for delivering the implant. At that point, the sleeve must beremoved prior to advancing the distal end of the delivery system intothe body of the patient. One convenient way to strip off the sleeve isto include with the sleeve an elongate pull element that will, when itpulled in the proper direction, part the sleeve progressively, from oneend of the sleeve towards the other1 to release the hoop stress in thesleeve and release the sheath from the surrounding sleeve. One need onlythink of the way in which the clear plastic film around a packet ofcigarettes is released from the cigarette packet to understand how anysuch elongate pull element might work. To assist the operation of thepull element in the environment of an operating theatre, the inventorcontemplates providing the free end of any such pull element with afinger ring to receive a finger and serve as a pull ring to pull thepull element to part the sleeve. The inventor envisages making thesleeve of a PET material (polyethylenephthalate) The above mentionedself-expanding implant release system that relies on a sheath thatdoubles back on itself will work optimally only when the sheath materialcan slide on itself, so that the outer of the two coaxial layers of thesheath can easily slide proximally over the abluminal surface of theinner layer of the sheath. Suppose that such a doubled back sheath isconfined inside a surrounding sleeve that imposes uniform pressure onall parts of the surface of the outer layer of the doubled back sheath.It is not inconceivable that there will be some tendency for the twofacing layers of the sheath somehow to “stick” to each other, at leastlocally. Self-evidently, it is important that the confining sleeve shallnot induce such adherence between the two facing layers of the sheathconfined within it. Preferred embodiments of the present invention offerimproved prospects to defeat any such tendency for adherence between thetwo layers of a roll back sheath.

Specifically, a preferred system according to the present invention willinclude means to establish spaced pressure relief zones interposedbetween the sheath and the sleeve for preferentially carrying the forcesacting between the sheath and the sleeve, whereby zones of the sheaththat lie between adjacent pressure relief zones are relieved of the fullmagnitude of said forces.

In other words, by confining to particular pressure zones the radiallyinward squeezing action of the sleeve on the sheath1 the interveningparts of the surface area of the sheath will be spared the radiallyinward pressure and so the outer of the two facing layers of the sheathwill not be pressed with full force against the abluminal surface of theinner of the two sheath layers. Indeed, with careful design of thesleeve system, it ought to be possible to arrange for there to be aphysical gap between the abluminal surface of the inner sheath layer andthe luminal surface of the outer sheath layer, in locations between twoadjacent pressure zones. Skilled readers will appreciate thatconfinement of the full squeezing force of the sleeve on the sheath tospecific spaced zones interspersed with pressure relief zones offers thepossibility to neutralize any tendency for the two sheath layers tostick to each other in the pressure zones.

This is particularly the case if the pressure zones are confined tolines of contact on the abluminal surface of the outer layer of thesheath that run parallel to the axis of the sheath and implant. This isbecause any such line of contact, where sticking is likely to occurpreferentially, runs along the length of the implant and thereforeshould present a minimal sticking problem when the sheath isprogressively peeled backwards along the length of the implant from itsdistal end to its proximal end.

Specifically, suppose there are six lines of contact between the sleeveand the sheath, evenly distributed at 60° intervals around thecircumference of the sheath. After the sleeve has been removed, and thesheath is pulled proximally to release the implant, we can take it thatany sticking is likely to be found at one or more of those six points ofcontact distributed evenly around the circumference. However, when mostof the circumference of the sleeve is peeling back from any sticking,such adherence as is to be found at the six points of contact is brokenby shearing and so ought to provide hardly any impediment to the smoothand progressive rolling back of the sheath membrane to release theimplant.

One way to provide a plurality of such lines of contact parallel withthe axis of the sheath and implant is to provide between the sheath andthe sleeve a plurality of elongate members, evenly distributed aroundthe circumference of the sheath and sleeve and all parallel to the axisof the sheath and implant. It may be useful to provide such elongatemembers as tubes. It may be optimal to select the tube diameter and thenumber of tubes such that they are in close proximity, or even incontact with each other, in the annular gap between the sheath and thesleeve. In one preferred embodiment, for example, there are six suchtubular elongate members, thus with their long axis at spaced intervalsof 60° around the circumference of the axis of the implant. Anotherpossibility is four tubes at 90° intervals parallel but spaced apartfrom each other.

Skilled readers will appreciate that there is no absolute need to haveadjacent elongate members in continuous contact with each other,side-by-side, over the full length of the implant. When there are enoughpoints of contact distributed along the length of the elongate members,at spaced intervals, there is no need for any such side-by-side contactbetween the spaced contact points. If spacers are used, there need be nocontact at all between the adjacent elongate members. In the illustratedembodiment described below, it is shown how wall portions of elongatetubular members can be selectively removed to provide spaced points ofside-by-side contact but a continuous line of contact of each elongatetubular member with the sheath confined radially within it.

It will likely be convenient and effective to provide theabove-mentioned elongate members as components made of metal. It isenvisaged that the extra cost to a delivery system for an implant causedby the provision of the elongate members and sleeve will be minimal inrelation to the performance advantages obtainable, particularly inrelation to the storage periods and temperatures that are liable to beencountered in practical day-to-day use of such implant deliverysystems.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the present invention, and to show moreclearly how the same may be carried into effect, reference will now bemade, by way of example, to the accompanying Drawings, in which:

FIG. 1 is a section taken transverse to the long axis of the distal endof a delivery system for a self-expanding implant;

FIG. 2 is a section taken in a plane normal to the long axis of thedistal end of a delivery system for a self-expanding implant; and

FIG. 3 is an isometric view through an assembly of elongate membersapplicable to the embodiment shown in section in FIG. 1 together with anexample of an isolated elongate member for use in such an assembly.

DETAILED DESCRIPTION

There now follows a description of one exemplary embodiment for puttingthe present invention into effect.

FIG. 1 shows a first embodiment of the present invention, being adelivery system for a self-expanding implant to line a bodily lumen. Theinner components of the delivery system are essentially conventional,but will be described here to aid the reader in understanding theinteraction between the various components of the system.

Defining an axis of the delivery system is inner catheter 11, which runsfrom a distal end of the delivery system (on the left hand side of theFigure) to a proximal end of the deli very system (not shown in theFigure but some distance beyond the right hand of the Figure).

Inner catheter 11 defines a lumen through which guide wire 2 runs. Guidewire 21 is provided to be inserted percutaneously and guided through thebody passages which the stent deliver system is to navigate before thedeli very system itself i introduced, in order to more easily guide theproximal end of the stent delivery system to its intended location inthe body.

Coaxial with the inner catheter, and located around it in a compressedconfiguration is implant 31, in the present instance being aself-expanding NITINOL stent. The stent is held in a radially compressedconfiguration onto the inner catheter by means of inner sheath layer 41,which radially surrounds the stent and applies inwardly radial pressurethereto to maintain the stent in its compressed configuration. In thesystem depicted, inner sheath 41 extends distally and then folds back onitself at a distal turning point to return proximally as outer sheath42. This configuration is conventionally known as a roll-back design/aswill be explained later in terms of stent deployment.

Outer sheath 42 extends proximally until a region A, where its radiusreduces to that of pull portion 51, where it attaches. Pull portion 51extends proximally to the proximal end of the deli very system to conveyan actuating tensile force from the operator to outer sheath 42. Incontrast, push element 61 is provided to restrain the stent 31 fromproximal axial movement relative to inner catheter 11. Accordingly, pushelement 61 is provided fixed in relation to inner catheter 11, in someembodiments by means of the inward pressure of inner sheath 41.Atraumatic tip 91 is provided distal of stent 31 to shield the distalend of inner sheath 41 and outer sheath 42 from the body passagesthrough which the stent delivery system travels, and vice versa.

What has been described so far is for the most part conventional.However, the embodiment shown in FIG. 1 also provides a confiningstructure 80, including rod members 81 a, 81 b, 81 c, 81 d, 81 e and 81f 1 of which only 81 a and 81 d are shown. The rod members lieessentially parallel to inner catheter 11 at substantially equalcircumferential spacings therearound and are confined themselves bysleeve 82. The radial configuration is shown in FIG. 2, in which thestructures inward of outer sheath 42 have been simplified for clarity.

Confining element 82, here being a confining sleeve, provides inwardradial pressure on the rods, which themselves provide inward radialpressure on outer sheath 42 at each of the six points of contact of therods to the outer sheath around the circumference thereof. On the otherhand, between the points of contact no pressure is applied. This can beseen more easily in FIG. 2, including the phenomenon of closecompression of the layers 41, 42 at the contact points of the rods 81,while voids 71 exist between layers 41, 42 at regions between the pointsof rod circumferential contact.

By applying this radial compression to outer sheath 42, the tendency ofstent 31 to distort, by virtue of its natural tendency to expand andthus apply radial pressure, inner and outer sheaths 41 and 42 isinhibited.

Prior to use in surgery, the stent delivery system is provided in theform shown in FIG. 1 in which it may be stored for an extended period.

The user, just prior to surgery, removes the confining structure 80, by,for example, splitting sleeve 82 and discarding the rods 81. The stentwill then be available for use in its design-intended configuration,having dimensions and geometry undistorted over time by the agingprocess.

Next, the guide wire is inserted into the body percutaneously andnavigated beyond the stent site. The delivery system is then directedalong the guide wire to reach a particular body lumen, for example acardiac artery. In the configuration of stent shown in the presentembodiment, the pull element 51 is then retracted by application oftensile force from the proximal end of the system. The outer sheath 42thus slides proximally over inner sheath 41 such that the folded portiondistal of inner sheath 41 and outer sheath 42 progressively rolls backto expose the stent. Meanwhile, push element 61, being coupled to innercatheter 11, which is held static at the stenting site by compressionforces from the proximal end of the system/restrains the stent fromproximal movement to ensure accurate deployment at the intended stentingsite. As the pull element is retracted, radial pressure is released onthe stent and stent 31 assumes its expanded configuration, such that theinner radial void of the stent becomes larger than atraumatic tip 91,and the stent engages with the walls of the bodily lumen.

The stent delivery system may then be swiftly and easily retracted theway it arrived, leaving the stent secured in place.

Of course, many other configurations of stent delivery system thanroll-back systems may be used in conjunction with confining structure80. Indeed, confining structure 80 provides an effective means ofcontaining any self-expanding implant delivery structure which isotherwise liable to expand over time and therefore potentially exceedits design tolerances. For example, confinement structure 80 can be usedwith stent delivery systems having pull-back, rather than roll-back,sheaths.

The construction of elements within confining structure 80 may be, ashas been mentioned, conventional. On the other hand, the innovativeconfining structure 80 may itself be realized in a number of differentforms. Considering the arrangement of FIGS. 1 and 2, confining structure80 is provided as longitudinal rods spaced equidistantly about thecircumference of the outer sheath 42, but other configurations to thoseshown in FIG. 1 are entirely possible.

For example, the rods may instead be formed as hollow cylinders and/ortheir arrangement and spacing around the circumference of the outersheath may be varied. For example, four rods or eight rods may becontemplated, and their diameter varied in comparison to the diameter ofthe outer sheath.

In some embodiments, a split-wire 83, shown schematically in FIG. 2, maybe provided, running the length of the sleeve, to enable the user toeasily and swiftly split the sleeve before use, without the use of aseparate tool. Such a split-wire may run distally (portion 83 a) withinthe sleeve between two of the rods and may then loop at the distal endbefore returning (portion 83 b) to the proximal end on the outside ofthe sleeve, terminating in a pull-ring 84. Pulling on the pull-ring willthen cause the wire to split the outer sleeve longitudinally, distal toproximal. Thin steel wire is suitable as a split-wire, in someembodiments.

In one embodiment, the rods do not touch but approach each otherclosely. This permits a high degree of contact with the outer sheath andconfinement thereof while preventing variations in confining force orinability to sufficiently compress due to the rods touching one toanother. In another embodiment, the rods are configured to touch oneanother at a desired level of confining pressure or confining diameter,to prevent the inner components of the stent delivery system becomingcrushed by overpressure.

In the above embodiment, the conventional stent structure lying withinthe confining structure, namely that lying within the radius of theouter sheath, typically has a diameter of around 2.4 mm. In such aconfiguration, stent diameters themselves of around 2.1 mm areconceivable, in their compressed state. Of course 1 in their expandedstate such stents typically achieve outer diameters of around 7 mm,depending on application. For such applications, rods of the confiningstructure having a diameter around 2 mm may be appropriate.

As to the other components, the atraumatic tip 91 is typically formedfrom polyurethane, the inner catheter is typically a polyimide tube,while the inner and outer sheaths are typically formed from 80/pm-thickPET which are respectively cold drawn (for the inner sheath) and heatshrunk (for the outer sheath) to a reduced thickness during manufacture.The thickness may be reduced from an original thickness of 80 pm down toa reduced thickness of 40 pm, in one exemplary embodiment. Furtherdetails of the construction of typical roll-back stent delivery systemsto which the present invention may be applied may be found in publishedpatent applications, such as WO 2006/020028 A1.

The rods are envisaged to be made from steel or polyamide, but othermaterials, including both metals and polymers, are well within thechoice of the skilled designer to select. However, both steel andpolyamide are considered to be especially able to give the requiredresistance to distortion preferred in embodiments of the presentinvention.

Indeed/if the rods are sufficiently resistant to deformation, it may notbe required to provide a sleeve running the entire length of theconfining structure, but to merely provide a number of compressingligatures spaced along the length of the rods, in the manner of thehoops used to compress a traditional barrel of beer, wine or ale.Therefore, another embodiment is possible wherein the outer sleeve isreplaced by a series of rings which may be slid along the rods torelease them. Alternatively, a clamshell clamping arrangement may beprovided around the rods, which arrangement may be released by a catchprior to use of the delivery system.

Another embodiment is contemplated having a configuration of confiningstructure as shown in FIG. 3. FIG. 3 does not show the inner stentdelivery components or the outer sleeve, but shows how a bundle of sixtubes may be arranged to perform the same function as the rods 81, eventhough portions of the tubes have been cut out circumferentially, exceptfor certain circumferentially intact portions spaced along the length.These uncut portions, having a complete circumference, transfer thecompressive force of the sleeve through the tubes to the confined innercomponents of the stent delivery system. On the other hand, where thecircumference is not complete, sufficient of the circumference remainsto provide a line of pressure along the stent delivery components toachieve the effects of the invention. In this embodiment, thecharacteristics of the material from which the tubes are formed willdetermine how closely the full-circumference portions need to be spacedand how much of the circumference may be removed in the interveningcut-out portions. However, it is envisaged that the advantages of thepresent invention may be obtained even when the cut-out portions retainonly around 130° of circumference each.

As to the construction of an embodiment of the complete confineddelivery system, starting from a complete conventional stent deliverysystem, the rods are located in their predetermined positions around theconventional delivery system and heat-shrink tubing applied to theoutside. This heat-shrink tubing is typically PET tubing which willshrink radially within around five seconds when a temperature of 200° C.is applied. During manufacture of stent delivery systems, it isgenerally considered highly undesirable to apply heat to a regionproximate to a compressed-shape memory stent, in case the memory of theexpanded configuration is distorted or destroyed, leading to potentialcatastrophic deployment failure. However in the described embodiment,heat-shrinking of the outer sleeve is entirely possible, since theintervening rods and air gaps provide sufficient insulation to preventeffective heat transfer to the stent during the period when theheat-shrink tube is heated to cause it to shrink and radially confinethe rods.

The present invention is not limited to the presently disclosedembodiments, but rather solely by the scope of the appended claims. Theskilled reader will easily contemplate how embodiments of the confiningstructure may be incorporated into other constructions of implantdelivery systems where dimensional creep due to aging is undesirable.Such embodiments may not be herein explicitly described, but withnevertheless be clearly within the ambit of the skilled reader withoutundue experimentation and without the exercise of inventive skill.

1. A delivery system for a self-expanding implant to line a bodilylumen, which includes a sheath to hold the implant in a radiallycompressed configuration prior to deployment in the lumen, when thesheath is withdrawn along the axis of the lumen, the system furthercomprising a confining element to surround the sheath during a storageperiod between placement of the implant within the sheath and saidwithdrawal of the sheath, the confining element serving to reduce thehoop stress in the sheath during said storage period and being removablefrom the sheath prior to advancement of the sheath into the bodilylumen, wherein the system includes means to establish spaced pressurerelief zones, interposed between the sheath and the confining element,for preferentially carrying the forces acting between the sheath and theconfining element, whereby zones of the sheath that lie between adjacentpressure relief zones are relieved of the full magnitude of said forces.